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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

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FCN No. 1443

Colors and Effects USA LLC

According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.
Food Contact Substance: Copper, [C,C,C,C-tetrachloro-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32] (CAS Reg. No. 27614-71-7).
Notifier: BASF Corporation
Manufacturer/Supplier: Colors and Effects USA LLC
Intended Use: As a colorant in all types of food-contact polymers, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The FCS is to be used at levels not to exceed 1 percent by weight of the food-contact polymer. The finished polymers are intended to contact all types of food under Conditions of Use C through G, as described in Table 2 of 21 CFR 176.170, not to exceed temperatures of 70 °C, and as a replacement for FCN 550. The FCS is not for use in contact with infant formula or breast milk. Such use was not included as part of the intended use of the substance in the FCN.
Effective Date: Aug 5, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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